InsightPFA试验的原理与设计：一项针对有症状的阵发性心房颤动中国患者，比较不可逆电穿孔脉冲场消融与射频消融的前瞻性、多中心、随机对照试验。

Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation.

作者信息

Lin Weidong, Pu Sijia, Chu Huimin, Chang Dong, Yin Xiaomeng, Wang Yuegang, Xu Yizhou, Li Shaolong, Yang Jian, Zhu Wenqing, Li Songnan, Gao Weidong, Chen Yanbo, Xu Dong, Jiang Chenyang, Xue Yumei

机构信息

Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.

School of Medicine, South China University of Technology, Guangzhou, China.

出版信息

J Cardiovasc Electrophysiol. 2025 Mar;36(3):632-641. doi: 10.1111/jce.16573. Epub 2025 Jan 24.

DOI:10.1111/jce.16573

PMID:39853845

Abstract

BACKGROUND

Pulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue-specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30-day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation-index (AI)-guided radiofrequency ablation (RFA) for PVI.

METHODS AND RESULTS

The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI-guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.

CONCLUSIONS

This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.

TRIAL REGISTRATION

https://www.

CLINICALTRIALS

gov/study/NCT06014996; NCT06014996.

摘要

背景

脉冲场消融（PFA）作为一种用于治疗心房颤动（AF）的非热、组织特异性技术正逐渐获得认可。对Insight Medtech有限公司所研究的新型PFA系统进行的临床前评估已证明其在猪模型中进行肺静脉隔离（PVI）的可行性、安全性及30天疗效。我们目前正在进行一项随机对照试验，以将PFA与用于PVI的消融指数（AI）引导下的射频消融（RFA）进行直接比较。

方法与结果

InsightPFA试验是一项前瞻性、多中心、随机对照试验，旨在比较PFA与RFA对有症状阵发性AF的中国患者进行PVI的有效性和安全性。292例被诊断为有症状阵发性AF的患者将按1:1的比例随机分配至PFA组或RFA组。所有受试者将使用PFA或AI引导下的RFA进行PVI，并随访12个月。主要终点定义为在90天空白期后的9个月随访期内，在未使用I类或III类抗心律失常药物的情况下无任何AF/AFL/AT发作。有效性的次要终点包括急性治疗成功率和手术数据。安全性评估包括死亡、中风和短暂性脑缺血发作、手术相关并发症、设备相关不良事件及严重不良事件的综合情况。将在有效性和安全性方面对新型PFA系统与现有RFA系统进行非劣效性比较。